Uterine FibroidsEarly Phase 1NCT00584207
Radiofrequency Ablation of Uterine Fibroids
A Early Phase 1 study testing radiofrequency ablation in people with Uterine Fibroids, run by University of California, Davis at 1 site in United States.
Trial summary
This research study is being conducted to evaluate the safety and effectiveness of ablation (destruction) of uterine leiomyomas (fibroids) using electrocautery heating guided by ultrasound. We are doing this to look for a less invasive method of treatment for patients with uterine fibroids. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- radiofrequency ablation
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Jul 2008
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Diagnosed with uterine leiomyomas (fibroids)
- Patient will undergo surgical hysterectomy
- Patient is willing to sign informed consent form
Who cannot join
- Patients with acute infection
- Patients with bleeding disorders
- Patients who are not candidates for surgery or general anesthesia
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
This research study is being conducted to evaluate the safety and effectiveness of ablation (destruction) of uterine leiomyomas (fibroids) using electrocautery heating guided by ultrasound. We are doing this to look for a less invasive method of treatment for patients with uterine fibroids. One method that is being used in other areas of the body to treat masses is radiofrequency electrocautery. This method may be performed for the treatment of uterine fibroids by placing a small diameter needle through the wall of the vagina into the fibroid guided by an ultrasound probe. An optional approach is to place the needle through the skin of the abdomen into the fibroid guided by an ultrasound probe. Once the needle is in the fibroid, the electrocautery current is applied and the fibroid is destroyed by heating. This would be done before hysterectomy (removal of the uterus). We are trying to test to see if this type of treatment can be applied to uterine fibroids. We are trying to develop radiofrequency electrocautery as one of the methods to treat fibroids without surgery.
- Conditions
- Uterine Fibroids
- Being tested
- radiofrequency ablation
- Keywords
- uterine fibroids
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency ablationProcedure or surgery
Intraoperative RFA of uterine fibroids
What is being measured
The primary outcome is the main question the study is designed to answer.
Following the hysterectomy, the study pathologist will perform a histological examination of the treated fibroid specimen to determine the size and volume of the ablation that was created with radiofrequency electrocautery.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startMar 2004
- Primary completionMar 2007
- Study completionJul 2008
Why it stopped: Unsufficient referrals for recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Investigators
- John P. McGahan, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584207
- Sponsor's protocol ID
- 200412085
- Status last verified
- Apr 2009
- First submitted
- 21 Dec 2007
- Last updated
- 23 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation of Uterine Fibroids
- ClinicalTrials.gov ID
- NCT00584207
- Acronym / sponsor ID
- 200412085
- Conditions
- Uterine Fibroids
- Keywords
- uterine fibroids
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unsufficient referrals for recruitment
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 2 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is being conducted to evaluate the safety and effectiveness of ablation (destruction) of uterine leiomyomas (fibroids) using electrocautery heating guided by ultrasound. We are doing this to look for a less invasive method of treatment for patients with uterine fibroids. One method that is being used in other areas of the body to treat masses is radiofrequency electrocautery. This method may be performed for the treatment of uterine fibroids by placing a small diameter needle through the wall of the vagina into the fibroid guided by an ultrasound probe. An optional approach is to place the needle through the skin of the abdomen into the fibroid guided by an ultrasound probe. Once the needle is in the fibroid, the electrocautery current is applied and the fibroid is destroyed by heating. This would be done before hysterectomy (removal of the uterus). We are trying to test to see if this type of treatment can be applied to uterine fibroids. We are trying to develop radiofrequency electrocautery as one of the methods to treat fibroids without surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Diagnosed with uterine leiomyomas (fibroids)
- Patient will undergo surgical hysterectomy
- Patient is willing to sign informed consent form
Key exclusion criteria (3 listed)
- Patients with acute infection
- Patients with bleeding disorders
- Patients who are not candidates for surgery or general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiofrequency ablationIntraoperative RFA of uterine fibroids | Procedure or surgery | – |
Primary outcome
Following the hysterectomy, the study pathologist will perform a histological examination of the treated fibroid specimen to determine the size and volume of the ablation that was created with radiofrequency electrocautery.
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Unsufficient referrals for recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2009.
Related trials for Uterine Fibroids
Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John P. McGahan, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing radiofrequency ablation in people with Uterine Fibroids, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unsufficient referrals for recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Following the hysterectomy, the study pathologist will perform a histological examination of the treated fibroid specimen to determine the size and volume of the ablation that was created with radiofrequency electrocautery. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2009.